Vivos is a system of custom oral appliances designed to treat obstructive sleep apnea (OSA) and snoring by gradually expanding the jaw and widening the airway over roughly 9 to 18 months. Unlike CPAP machines, which keep the airway open with pressurized air every night for life, Vivos aims to physically reshape the structures around the airway so that treatment eventually ends. The system received FDA clearance for treating severe obstructive sleep apnea in 2023, making it the first oral appliance cleared at that severity level.
How Vivos Appliances Work
The core idea behind Vivos is that many people with sleep apnea have underdeveloped jaws or narrow palates that crowd the airway. Rather than managing the obstruction each night, Vivos applies gentle mechanical pressure to widen the dental arch and reposition the jaw forward. Over time, this creates more physical space for air to flow through the upper airway.
You wear a custom-fitted removable appliance for about 10 to 12 hours per day, typically during the evening and overnight. A trained dentist adjusts the appliance at regular appointments, gradually increasing the expansion. The average treatment time in FDA-submitted data was 9.7 months, though individual courses run anywhere from 9 to 18 months depending on severity and how the jaw responds.
The Different Vivos Devices
Vivos offers a suite of three main appliances under its CARE (Complete Airway Repositioning and/or Expansion) product line:
- DNA (Daytime-Nighttime Appliance): The flagship device, focused on upper jaw expansion.
- mRNA appliance: Targets both the upper and lower jaw, combining expansion with repositioning.
- mmRNA appliance: A variation designed for additional lower jaw advancement.
Your provider selects the specific device based on your anatomy and the severity of your sleep apnea. All three are removable and worn on a similar daily schedule.
FDA Clearance and What It Covers
The Vivos CARE appliances hold FDA 510(k) clearance for reducing nighttime snoring and treating mild and moderate obstructive sleep apnea in adults 18 and older. For moderate and severe OSA, the clearance specifies that the devices should be used alongside positive airway pressure (PAP) therapy and/or myofunctional therapy as needed. This means Vivos is not cleared as a standalone treatment for the most severe cases.
An interesting detail from the FDA submission: treatment results were actually better in patients with severe OSA compared to those with mild-to-moderate cases. The reason likely relates to the degree of structural narrowing. People with the most constricted airways may see the largest functional improvement from expansion.
Clinical Results
In a pediatric clinical trial published by Vivos, 79% of patients showed improvement in their sleep apnea after 12 to 24 months of treatment, with nearly 62% improving by 50% or more. Among children with severe OSA specifically, 93% saw their symptoms decrease by at least 50%. About 17% experienced full resolution of their condition.
These numbers come from a relatively small study of 47 participants, and they focus on children, whose bones are more responsive to expansion than adult bone. Results in adults may differ, and long-term data on whether airway changes hold permanently is still limited. That said, the FDA clearance for adults was granted based on separate submitted data showing meaningful reductions in the standard measure of sleep apnea severity.
What Treatment Feels Like
Most people experience an adjustment period with each new setting of the appliance. Common side effects include tooth soreness, jaw stiffness, and excess salivation in the early weeks. Some patients notice temporary tooth movement that may require minor orthodontic alignment afterward. Permanent bite changes are possible but rare.
The appliance itself is removable, so you take it out for meals and daily activities that require it. Because you wear it 10 to 12 hours per day, most of that time overlaps with sleep. Compared to CPAP, which requires a mask, hose, and powered machine every night indefinitely, the wearing experience is simpler, though the adjustment soreness is something CPAP users don’t deal with.
Cost and Insurance Coverage
Vivos treatment has historically been an out-of-pocket expense for most patients, with costs varying by provider and the specific appliance used. That landscape shifted in late 2024 when the American Medical Association issued new billing codes specifically applicable to all Vivos CARE devices, effective January 1, 2025. Vivos also received Medicare coverage approval shortly before that.
These coding and coverage milestones mean commercial insurance payers now have a standardized way to process claims for Vivos treatment. Whether your specific plan covers it will depend on your insurer, your diagnosis, and your plan details. If you’re considering Vivos, ask your provider’s office about insurance verification before starting.
How to Find a Vivos Provider
Vivos appliances are prescribed and managed by dentists who complete specialized training through the company’s Vivos Integrated Practice (VIP) program. This training covers case selection, treatment planning, appliance design, and adjunctive therapies, delivered through a combination of online coursework and hands-on, in-person sessions at the company’s Institute for Craniofacial Sleep Medicine.
Not every dentist offers Vivos. Because the system requires specific training and ongoing adjustments over many months, you’ll typically find it at practices that focus on sleep dentistry or airway-focused care. The Vivos website maintains a provider directory searchable by location. Before committing, confirm that your provider has completed the full certification program and has experience managing cases similar to yours.
Vivos vs. CPAP and Surgery
CPAP remains the gold standard for obstructive sleep apnea. It works immediately, has decades of data behind it, and is effective across all severity levels. The tradeoff is that it only works while you’re wearing it, and many people struggle with long-term compliance. Studies consistently show that a significant percentage of CPAP users abandon the therapy within the first year.
Surgical options like Inspire (a nerve-stimulating implant) offer another alternative, but they involve an invasive procedure, general anesthesia, and a permanently implanted device. Vivos sits between these approaches: non-invasive and time-limited, but with less long-term outcome data than either CPAP or established surgical methods. For people who can’t tolerate CPAP and want to avoid surgery, Vivos represents a meaningful option, particularly now that it carries FDA clearance and insurance pathways are opening up.